Analytical and bioanalytical assay challenges to support comparability studies for biosimilar drug development


Biopharmaceutical products (biologics) are active drug substances produced by living cells or derived from a living organism (bacteria, yeast, animal or human cell lines). Biosimilars, or follow-on biologics, are the subsequent versions of originator biopharmaceutical products following expiry of its patent and exclusivity. Biosimilars are also referred to as subsequent entry biologics in Canada. While the market for biosimilars is growing, few have been approved. Reports show that the world biosimilar market is expected to reach annual growth rates in excess of 50% between 2010 and 2015. This increase is, in some part, driven by the Asian market (one-third of the market) and also due to the strong global push for more affordable healthcare. In the USA, to improve access, Congress passed the biologics Price Competition and Innovation Act of 2009, authorizing the US FDA to oversee an ‘abbreviated pathway’ for approval of biologics that are ‘biosimilar’ to already-approved products.

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